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NCT Number: NCT07230600

AD-SVF Therapy for Refractory Endometrial Infertility

The purpose of this study is to initially explore the efficacy of adipose-derived stromal vascular fraction (AD-SVF) therapy in the treatment of refractory endometrial infertility.

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Key information

Age range

22 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location status: Recruiting

Location contact

Yali Hu

CONTACT

[email protected]

025-83106666 ext. 11201

About this study

Patients with refractory thin endometrium (endometrial thickness < 6 mm at late proliferative phase or after high-dose estrogen therapy) and/or moderate to severe intrauterine adhesion are recruited for fertility. After detailed explanation of the treatment plan, written informed consent will be obtained from the patients. The subjects undergo liposuction performed by plastic surgeons to obtain adipose tissue, from which AD-SVF is isolated and extracted for intrauterine infusion therapy. Six months post-AD-SVF treatment, the improvement in menstrual volume and endometrial thickness will be assessed during follow-up visits. The subjects will be advised, based on their personal inclination, to attempt conception (hysteroscopic surgery will be repeated if necessary), and their early pregnancy outcomes will be documented in subsequent follow-ups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • refractory thin endometrium (endometrial thickness < 6 mm on the day of ovulation or the day of endometrial transformation during a hormone replacement cycle) and/or moderate to severe intrauterine adhesion;
  • Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant effect following the BMSC treatment;
  • with fertility intentions;
  • normal ovarian function or availability of cryopreserved embryos;
  • 18kg/m^2 < body mass index (BMI) < 30kg/m^2;

Exclusion criteria

  • Chromosomal karyotype abnormalities in one spouse;
  • Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
  • Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the study's progression (uncontrolled hypertension, diabetes, autoimmune diseases, etc.);
  • Contraindications for pregnancy;
  • Contraindications for hormonal cycle therapy;
  • History of pelvic tumors;
  • Simultaneous participation in other clinical studies.

Treatment and study plan

AD-SVF

Biological

AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.

Primary outcomes

  1. Proportion of patients with endometrial thickness of 6 mm or greater

    Time frame: 6 months after AD-SVF intrauterine infusion therapy

    During the late proliferative phase, the endometrial thickness between anterior and posterior uterine walls is measured to be at least 6 mm through a median sagittal section of the uterus at least once.

Secondary outcomes

  1. Menstrual flow score at the 2nd month post-treatment

    Time frame: 2 months after AD-SVF intrauterine infusion therapy

    2 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.

  2. Menstrual flow score at the 6th month post-treatment

    Time frame: 6 months after AD-SVF intrauterine infusion therapy

    6 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.

  3. Chemical pregnancy

    Time frame: 9 months after AD-SVF intrauterine infusion therapy

    Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation.

  4. Clinical pregnancy

    Time frame: 9 months after AD-SVF intrauterine infusion therapy

    Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity at 6-8 weeks of gestation.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Zhu

CONTACT

[email protected]

86-025-83106666 ext. 54330

Yali Hu

CONTACT

[email protected]

86-025-83106666 ext. 11201

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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